Clinical Development Scientist, Senior Manager

Role: Senior Manager Clinical Development Scientist overseeing clinical trials in Internal Medicine, focusing on data integrity, scientific oversight, and quality assurance for multiple studies. Responsibilities include supporting protocol development, contributing to study design, safety review, data review, and regulatory documents, as well as managing external Data Monitoring and Adjudication Committees. The role involves clinical input on safety, risk management, site selection, investigator training, and contribution to study reports and publications. Requirements: PhD, PharmD, or equivalent with a minimum of 1 year (PhD) or 5 years (MS) or 6 years (BA/BS) of industry clinical research experience, with preferred expertise in cardiometabolic diseases such as obesity or diabetes. High-value specifics: experience with global regulatory compliance, GxP, and clinical trial conduct in biopharma, including protocol authoring, safety monitoring, and regulatory submissions. Stakeholder interaction includes study teams, investigators, and health authorities. The position is hybrid, requiring onsite work ~2.5 days/week, with potential for global travel. Leadership qualities such as mentoring, conflict resolution, and strategic thinking are essential, with a track record of scientific productivity and regulatory knowledge in clinical development.